FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
INTEGRATED MEDCRAFT LLC
The hazard
Devices could potentially contain an occluded or partially occluded Guedel Airway tip. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model FORWARD Oral Airway Kit (OPA Sizes 5Model 6.5Model 12). REF Number: 1011-40002. Lot Numbers: IMC-00000060Model IMC-00000066Model IMC-00000078Model IMC-00000086Model IMC-00000092Model IMC-00000096Model IMC-00000097Model IMC-00000103Model IMC-00000110Model IMC-00000125Model IMC-00000151Model IMC-00000200Model IMC-00000201Model IMC-00000204Model ISO 5.0Model blue. Product Code: 1100050. Lot Numbers: 32121232Model 32208193Model 32400267Model 32403734Model 32408819Model 32409672Model 32416545Would you have heard about this one?
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